Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area

The University of Texas System (UT)

Status: Enrolling

Conditions: Cardiometabolic Health; Child Obesity

Treatments: Other: Brighter Bites

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06570707

HSC-SPH-23-0282

5U54CA280804-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

Full description

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Enrollment: 720 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• enrollment of 100 1st, 2nd, and 3rd grade students
• high proportion of children participating in the free and reduced lunch (FRL) program (>70%)
• willingness to implement a coordinated school health (CSH) program

Exclusion criteria

• Prior participation in BB in the previous school year
• children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

Brighter Bites

Experimental group

Description:

This group will receive the Brighter Bites intervention throughout the study implementation. The intervention includes fruit and vegetable distributions of \~20lbs. for teachers and families, healthy recipe tastings, and nutrition education.

Treatment:

Other: Brighter Bites

Control group

No Intervention group

Description:

This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.